Study on the Safety of Risperidone on Obese or Overweight Patients With Schizophrenia

Terminated

• Conditions: Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder
• Interventions: Drug: Risperidone

• Registration Number: NCT00511628
• Lead Sponsor: Janssen-Cilag, S.A.

Brief Summary

The purpose of this study is to evaluate the safety of risperidone treatment in patients who are overweight and/or obese.

Detailed Description

This is an observational, multicenter, open and prospective study. The primary objective is to evaluate safety of risperidone in patients who are overweight and/or obese. It is expected to enroll 1500 patients with Schizophrenia or Schizoaffective disorder, in which physicians considered the use of risperidone as treatment under clinical practice with a BMI (Body Mass Index) \>25, or for patients that have increased their body weight \>7% in the last year with the previous treatment (even with a BMI\< 25), and for patients that have shown intolerance to a previous antipsychotic treatment. The study drug is risperidone, 3-6 mg per day, orally, during the study period (6 months). All data collected will be prospective and will include the following: demographic data, psychiatric history and comorbidities, concomitant treatment, body weight, treatment history , other illness related to obesity ( such as diabetes mellitus I \& II, hypertension and hypercholesterolemia) and adverse events. Observational Study: Risperidone, 3-6 mg per day, orally, during the study period (6 months).

Study Timeline

• Study Start: 2001-07
• Study Completion: 2003-01
• Study First Submitted: 2007-08-02
• Study First Submitted QC: 2007-08-02
• Study First Posted: 2007-08-06
• Status Verified: 2011-03
• Last Update Submitted: 2011-05-18
• Last Update Posted: 2011-05-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1717

Inclusion Criteria

• Patients with Schizophrenia or Schizoaffective disorder, in which physicians considered the use of risperidone as treatment under clinical practice with a BMI >25
• Patients have increased their body weight >7% in the last year with the previous treatment even with a BMI< 25
• Patients that have shown intolerance to a previous antipsychotic treatment

Exclusion Criteria

• Pregnant or lactating patients
• Patients with psychiatry pathology other than Schizophrenia or schizoaffective disorder
• Patients with neurology pathology except Parkinsonism induced by neuroleptics
• Patients with other severe concomitant pathology
• Patients treated with Risperidone in the last 30 days.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
001	Risperidone	Risperidone As prescribed

Primary Outcome Measures

Name	Time	Method
Safety Evaluation of Risperidone in patients who are overweight and/or obese	6 months

Secondary Outcome Measures

Name	Time	Method
Effectiveness	6 months